Deeming Regulations: Can Vaping Survive?

The FDA’s deeming regulations are the 800-pound gorilla in the American vaping world. Everyone has heard something about them, but there are many misconceptions. Here’s the story.

With these regulations, the FDA is literally deeming (or defining) e-cigs to be a tobacco product, which allows them to then be regulated under the authority of the Family Smoking Prevention and Tobacco Control Act of 2009. Mitch Zeller, head of the FDA’s Center for Tobacco Products, has said that the deeming regulations are a “foundational” step — a basis for additional rules in the future. Once in effect, the FDA will be free to add all sorts of restrictions without real opposition.

What is in the regulations? We can’t be certain, since nobody has seen the current version. But based on what was released last year before the public comment period, we can make some educated guesses. Attorney Azim Chowdhury wrote an excellent summary of the deeming regs last year that is a good starting point. NotBlowingSmoke.org also maintains a site dedicated to the issue.

Regulation or a virtual ban?

The FDA seems determined to create requirements for manufacturers (including producers of e-liquid) that will be so expensive that no businesses except the major tobacco companies will be able to afford them. Only products that were on the market and being sold in the US before February 15, 2007 (the “grandfather date”) will be exempt from applying as new products for FDA approval.

Since virtually nothing being sold currently was on the market in 2007, that means all of the products we use now would be illegal to sell — unless the manufacturer applies for and receives approval as a new product.

Cost estimates range from $300,000 to $10,000,000 to complete a Premarket Tobacco Application (PMTA) for each product.

For e-liquids a separate application would be required for each flavor, and at each nicotine strength, and in each PG/VG mix.

By the way, applying doesn’t guarantee approval. It is quite likely that a manufacturer could spend millions of dollars and a year’s time jumping through all the hoops of submitting an application only to have it denied. The cost and the risk of denial are why many vaping advocates call the deeming regulations a virtual ban.

Where do we stand now?

Since last year’s comment period, the FDA fine tuned the regulations, and in October sent them to the White House Office of Management and Budget (OMB) for review. The OMB has just finished meeting with interested parties – including many manufacturers, shop owners, advocates, and representatives of trade associations, think tanks and consumer groups. They’ve also met with many groups that are opposed to e-cigs and want strong regulations.

Any day now, the OMB will choose to either send the regulations back to the FDA for further changes, or allow them to stand as they are. Once they make their determination, if no changes are required, the regulations will be published in the Federal Register, then go into effect after a brief public comment period.

What can we do now?

There is a legislative effort that could change the outcome to some extent. U.S. Rep. Tom Cole of Oklahoma has introduced HR 2058, which would prevent the FDA from applying the 2007 grandfather date to vapor products.

This would essentially save the whole U.S. industry — for now anyway. The bill needs co-sponsors in the House — other members to sign on to support the bill.

CASAA has an easy-to-complete form that sends a letter supporting HR 2058 to your representative just by entering your name and address. It takes just a minute to do, and could have a huge effect on the future of vaping.

While this fix would be helpful, the more likely scenario is that the deeming regs will go into effect, and then be fought in court. Who will sue? On what grounds? Who will pay for it? We don’t have answers to those questions yet. What is certain is that a legal solution will be a long, expensive and difficult process. Stay tuned!

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I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.

Nice post! Really gets at the reason why advocacy is so important now. Lawsuits are not ideal in this case. Vapers and businesses should be calling their representatives and fighting to protect this market, which is about to be trampled by these regulations. Part of the problem is that lots of vapers aren’t even aware that the FDA deeming regulations are as harmful to the industry as they are. This will completely stifle innovation, stores will close, and the market we know today will be gone… It’s crazy to think this, seeing as cigarettes are still legal and so much more dangerous – but this is what is most likely to happen at this point. The FDA is about to hand this industry over to the tobacco companies. A lot of politicians don’t recognize this!

Jim McDonald

100% correct. Thanks for the great comment!

John Dearing

I’m all for advocacy but honestly how often has our government paid attention to what we say? The FDA is not a federal agency that answers to congress ect… Niether is the EPA they can pretty much make the rules as they see fit. They recieve a large part of their funding from the pharmaceutical industry how’s that for a conflict of interest. I’m not sure what will happen but I’m ready to diy and help as many as I can stay off tobacco based products.

Jim McDonald

Our government does pay attention to those that demand it. Vapers need to be aware and engaged, and vapor businesses need to be united behind the organizations that provide lobbying muscle for them. It won’t be easy to win, but without a fight we’ll lose by default.

Michael Abrams

The issue I see is the US govt doesn’t have the infrastructure to keep tabs on industries that consist of a multitude of small businesses, either through taxation or regulation. Easier for them if vaping were in the hands of Altria and Reynolds, but they are geared towards making commodities, not rx200’s and tfv4’s with dozens of exotic coil options. hoped the Chinese would pool resources to meet FDA approvals,, but I think they would sooner abandon our market. Big tobacco purchased Blu, but cigalikes are commodities. I don’t see Altria acquiring Kanger or Aspire or SMOK Tech, but let’s hope I’m wrong. I have heard that Innokin and Joyetech have been in DC, pleading their case.

Jim McDonald

You’ve raised several interesting issues, Michael. If the tobacco companies are given the market (if they are the only ones able to afford complying with the regulations), will they bother investing in products that will compete with their cigarette business? Will the large Chinese manufacturers comply? And will they participate in what is certain to be a large black market? There are lots of uncertainties ahead.

Michael Abrams

Final point. If the US smoking rate reverts to 2007 levels, about 24% stated (but higher in reality), the FDA and/or big tobacco will have a lot of explaining to do. Adding 20 millions US vapers back to the ranks of analog consumers would look terrible, and it will be easy for everyone to tell who is responsible. Maybe only then will those making the opposition (including the daily media story- “ecig explodes in x state teen’s pocket”) come to their senses. Too much like alcohol prohibition in the 1920’s, and that took a long time to resolve.

Jim McDonald

You’re exactly right, and I don’t think the FDA honestly wants to have to defend that. They don’t *want* people to go back to smoking — I’m convinced — but the pressure to do something drastic is greater than the pressure not to. We need to keep applying pressure — on them, on Congress, and on the groups that spend the most energy arguing against vaping (the AHA, ALA, ACS, etc.).

By the way, I’m always happy to discuss this. I hope you’ll keep sharing what you think!

Joe Holland

I’m following the squeaky wheel approach.. I am contacting my state representative.

Jim McDonald

Yeah, that definitely good to do. Be sure to contact your U.S. House rep too, and ask him or her to co-sponsor HR 2058. Thanks for being a squeaky wheel!

Blackg

I believe our biggest issue with trying to change the general populations point of view on vapor products are the people in the industry that refuse to follow instructions and leave behind a bad reputation for every vaper out there. Because of the small portion of teens that use vapor products illegally and obnoxiously, they gave ammunition to the anti vaping groups, (who have hit my hometown Kansas city pretty hard). And then there are those that use their devices incorrectly, building too low, leaving batteries exposed, using the atomizers for drugs and other substances, being obnoxious in public. That paint a pretty terrifying picture on the industry. And the misinformation in the public like the diaceytal scare, while the research does support that it can be harmful the wonderfully self regulated industry took that information and made adjustments, juice manufactures like space jams recalled those flavors that included the chemical. While we can certainly make our voice heard in congress the louder protest from the rest of the nation will squelch us we need to become better as a group and try to change the publics view on us by presenting ourselves better. The tobacco industry has been for the most part left to itself because smokers weren’t in the front of everyone’s mind, they went to their smoking sections and didn’t shove tobacco in the face of every person against it. When we use our favorite product it’s up to us to present to the public that we aren’t a bunch of goofy kids that don’t know what from what and that we really understand our devices and use common decency when vaping in public.

Jim McDonald

Thanks for the thoughtful comment! I agree that each vaper needs to be aware that we represent vaping whenever we vape in public, but also when we discuss it with those who are unaware of the facts. I’m sure you do a great job standing up for vaping!